PROPEL corticosteroid‑releasing sinus implants — IBUKI cohort
Propel Drug-Eluting Sinus Implant Family IBUKI Cohort
This project tests how safe and well PROPEL corticosteroid‑releasing sinus implants work for people in Japan with chronic rhinosinusitis who undergo endoscopic sinus surgery.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Medtronic Industry-sponsored |
| Drugs / interventions | dupilumab, mepolizumab |
| Locations | 1 site (Asahikawa) |
| Trial ID | NCT07546682 on ClinicalTrials.gov |
What this trial studies
This is an observational, standard‑of‑care cohort that collects real‑world data on Japanese patients treated with the PROPEL family of corticosteroid‑eluting implants following functional endoscopic sinus surgery (FESS). Patients are eligible if they have confirmed chronic rhinosinusitis, undergo uncomplicated FESS, and receive successful placement of 2–4 implants per the implant instructions for use. The study captures safety events, clinical performance, and patient‑reported sinonasal outcomes (including the 22‑item SNOT) through postoperative follow‑up, with data collected according to routine clinical visits. No experimental interventions are administered beyond standard care and the specified implant and packing requirements.
Who should consider this trial
Good fit: Adults in Japan with confirmed chronic rhinosinusitis who are indicated for FESS, complete uncomplicated surgery, and receive 2–4 PROPEL implants per the device instructions are ideal candidates.
Not a fit: Patients who are not undergoing FESS, cannot receive the required implant placement, have significant comorbidities that limit survival or follow‑up, or require different hemostatic packing may not benefit from participation.
Why it matters
Potential benefit: If successful, the results could confirm that PROPEL implants provide safe, effective local steroid delivery after FESS and help reduce postoperative inflammation and symptom burden.
How similar studies have performed: Similar PROPEL implant programs and clinical reports outside Japan have shown favorable safety and improved sinonasal outcomes, so this study is primarily confirmatory in a Japanese population.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patient or legally authorized representative (LAR) provides authorization and/or consent per institution and geographical requirements * Patient has, or is intended to receive or be treated with, an eligible Medtronic product * Patient is consented within the enrollment window of the therapy received, as applicable * Patient has a confirmed diagnosis of CRS, and is indicated for FESS per Japan standard practice * FESS is successfully completed without the occurrence of major/significant complications that may confound study results * Successful placement of 2 to 4 corticosteroid-eluting implants in the ethmoid or frontal sinus (1 implant per sinus) in accordance with implant IFUs * NOVAPAK is the only hemostatic packing material placed bilaterally in ethmoid sinuses Exclusion Criteria: * Patient has clinical evidence of disease or a condition expected to compromise survival or ability to complete follow-up assessments through Month 6 (end of study) * Participation is excluded by local law * Patient is currently enrolled in, or plans to enroll in, any concurrent study that may confound the PSR results (i.e., no required intervention that could affect interpretation of all-around product safety and/or effectiveness) * Patient has received biologic medication approved for the treatment of CRSwNP (e.g., dupilumab, mepolizumab) in ≤ 12 weeks prior to the baseline/procedure visit * Patient is contraindicated in accordance with IFUs of PROPEL family implants and/or NOVAPAK
Where this trial is running
Asahikawa
- Japanese Red Cross Asahikawa Hospital — Asahikawa, Japan (Recruiting)
Study contacts
- Study coordinator: Katherine Schiller
- Email: katherine.schiller@medtronic.com
- Phone: 763-526-8329
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.